Process Validation Engineer

Job Description

Job Description

Responsibilities :

• We have defined processes, procedures, and testing in place to build our Class II medical device systems. They are built compartmentally (in stages), inspected, tested, and ultimately, delivered, installed, and turned over to the customer.
• Development and delivery of a close-loop validated process that ensures safe, consistent and effective production of a quality product (system).
• The individual for this role will create a (gap / needs analysis) and a plan of action to achieve the Desired State (DS) as defined above. Minimally, this will involve a review of existing procedures, processes, and a hands-on approach to gain a full understanding of how our systems are manufactured.
• Additionally, we have other processes (i.e. painting, welding, and possibly other processes that may require validation), of which, support is required.
• After the gap / needs analysis is completed, the scope of the role is that of a traditional process validation specialist encompassing the following responsibilities.
• Create detailed validation protocols that outline the procedures, acceptance criteria, and documentation requirements for process validation.
• Perform risk assessments to identify potential process failures and their impact on product quality and patient safety.

Requirements :